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ATTEMPT study : pooled- A nalysis of T rials on T hromb E ctomy in acute M yocardial infarction based on individual

ATTEMPT study : pooled- A nalysis of T rials on T hromb E ctomy in acute M yocardial infarction based on individual P atien T data. FRANCESCO BURZOTTA INSTITUTE OF CARDIOLOGY CATHOLIC UNIVERSITY OF THE SACRED HEART ROME, ITALY.

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ATTEMPT study : pooled- A nalysis of T rials on T hromb E ctomy in acute M yocardial infarction based on individual

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  1. ATTEMPT study: pooled-Analysis of Trials on ThrombEctomy in acute Myocardial infarction based on individual PatienT data FRANCESCO BURZOTTAINSTITUTE OF CARDIOLOGYCATHOLIC UNIVERSITY OF THE SACRED HEARTROME, ITALY CLINICAL TRIAL UPDATE IIIESC Congress 2009September 2nd 2009, Barcelona

  2. Co-Principal Investigator Maria De Vita Youlan GuTakaaki IsshikiThierry LefèvreAnne KaltoftDariusz DudekGennaro SardellaPedro Silva OrregoDavid AntoniucciLeonardo De LucaGiuseppe GL Biondi-ZoccaiFilippo CreaFelix Zijlstra Co-investigators ATTEMPT STUDY GROUP

  3. BACKGROUND(1) No reflow occurs frequently during PCI in STEMI and is associated with reduced survival Van’t Hof, Lancet 1997

  4. BACKGROUND(2) Randomized trials showed that the adjunct of thrombectomy, but not distal protection, reduces the risk of no-reflow as compared to standard PCI in STEMI patients Risk of failure to achieve ST-resolution Burzotta et al, Int J Cardiol 2007

  5. AIM OF THE STUDY TO ASSESS IF THROMBECTOMY IS ASSOCIATED WITH IMPROVED CLINICAL OUTCOME COMPARED TO STANDARD PCI BY POOLING THE INDIVIDUAL PATIENT DATA OF PROSPECTIVE RANDOMIZED TRIALS

  6. SAMPLE SIZING Long-term total mortality rate has been reported to be 3% in patients with post-PCI myocardial blush grade (MBG) 3 and of 29% in patients with post-PCI MBG < 3 (van ‘t Hof et al., Circulation 1998). The rate of post-procedural MBG 3 was reported to be higher in the thrombectomy group with an OR estimate of 2.3 (Burzotta et al., Int J Cardiol 2007). A sample size of 1350 patients (675 for each arm) was calculated to be needed to demonstrate, with an alpha risk of 5% and a beta risk of 20%, a survival advantage at one year using thrombectomy compared to standard PCI

  7. 5 trials 12 trials STUDY DESIGN* EuroPCR and TCT web-site search MEDLINE search 17 trials Principal investigators (PIs) have been contacted to provide data regarding the patients included in their study PIs of 11 trials agreed to participate the ATTEMPT DATABASE (patients pre-PCI characterictics and longest available clinical FU) * Published as full paper (De Vita et al, Vasc Health and Risk Management 2009) * Registered in clinicaltrials.org website NCT00766740

  8. DIVER CE De Luca REMEDIA PIHRATE MANUAL ASPIRATION PRONTO DEAR-MI EXPORT EXPIRA EXPORT TAPAS ANGIOJET Antoniucci 2686 pts X-AMINE ST X-SIZER NON-MANUAL THROMBECTOMY Median FU available for ATTEMPT study: 365 days (significantly extended compared to published median FU of included trials: 135 days) RESCUE Kaltoft TVAC VAMPIRE INCLUDED TRIALS

  9. 100% Thrombectomy 95% Standard PCI 90% CUMULATIVE SURVIVAL 85% 80% No previous report on outcome >1 year 300 days 600 days 900 days 1200 days TIME TO DEATH PRIMARY END-POINT P= 0.049 Absolute Risk Reduction: 1.6% Relative Risk Reduction: 29%

  10. OR 0.72 (0.47-1.10); P= 0.13 OR 0.87 (0.67-1.13); P= 0.27 OR 0.70 (0.52-0.93); P= 0.02 OR 0.80 (0.65-0.98); P= 0.03 3 0.5 1 2 0 Thrombectomy better Standard PCI better SECONDARY END-POINTS MI TVR Death or MI MACE

  11. MANUAL ASPIRATION TRIALS NON- MANUAL THROMBECTOMY TRIALS CUMULATIVE SURVIVAL CUMULATIVE SURVIVAL 100% 100% 95% 95% 90% 90% P= 0. 48 85% 85% 80% 80% 300 days 300 days 600 days 600 days 900 days 900 days 1200 days 1200 days TYPE OF THROMBECTOMY P= 0.011 Estimated number of pts to treat to save 1 life: 34

  12. Thrombectomy better Standard PCI better PRE-PCI SUBGROUPS Risk of death DIABETES IIb/IIIa INHIBITORS TIME TO REPERFUSION INFARCT RELATED ARTERY TIMI FLOW

  13. MORTALITY 7.4% 8% 6% 5.0% 4.8% 4% 3.3% 2% Thrombectomy±IIb/IIIa inhibitors P=0.02 IIb/IIIa inhib - Thrombectomy - IIb/IIIa inhib + Thrombectomy - IIb/IIIa inhib – Thrombectomy + IIb/IIIa inhib + Thrombectomy +

  14. CONCLUSIONS The present pooled analysis of individual patient data from 11 STEMI trials shows that: - Thrombectomy (in particular when performed by manual thrombectomy catheters) improves survival - Thrombectomy and IIb/IIIa inhibitors may synergistically improve the clinical outcome

  15. Available now online from European Heart Journal http://eurheartj.oxfordjournals.org/cgi/content/full/ehp348

  16. For further slides on these topics please feel free to visit the metcardio.org website:http://www.metcardio.org/slides.html

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